Identity
- Trade Name
- MOR® Surgical Kit - No Tools FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, medicated, reusable FDA UDI
- Device Name
- Intended to be used during implant surgical procedures to drill, bone tap or countersink bone or tissue in the mandible or maxilla of patient. This kit contains no surgical tools. FDA UDI
- Model / Reference
- 905252 FDA UDI
- Description
- Intended to be used during implant surgical procedures to drill, bone tap or countersink bone or tissue in the mandible or maxilla of patient. This kit contains no surgical tools. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549118432 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental/maxillofacial surgical procedure kit, medicated, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental/maxillofacial surgical procedure kit, medicated, reusable
MOR® Surgical Kit - No Tools by Sterngold Dental LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental/maxillofacial surgical procedure kit, medicated, reusable.
- Dowell Dental Products, Inc — Dowell Dental Products, Inc · Class I
- Dowell Dental Products, Inc — Dowell Dental Products, Inc · Class I
- Dowell Dental Products, Inc — Dowell Dental Products, Inc · Class I
- Dowell Dental Products, Inc — Dowell Dental Products, Inc · Class I
- Dowell Dental Products, Inc — Dowell Dental Products, Inc · Class I
- Dowell Dental Products, Inc — Dowell Dental Products, Inc · Class I
- Dowell Dental Products, Inc — Dowell Dental Products, Inc · Class I
- TRU®/PUR® Surgical Kit - No Tools — Sterngold Dental LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sterngold Dental LLC
Sources (1)
- FDA UDI 9714e9f6-5c06-40c5-af75-2db4f345ad71 34 fields · synced May 31, 2026